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Monaghan RVM Model 761

FDA 510(k)

Class II (US FDA 510(k))

510(k) K884942

by Monaghan Medical Corp.

Identifiers

510(k) Number
K884942 FDA 510(k)
FDA Product Code
BZK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1850 FDA 510(k)
Regulation Number
868.1850 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Monaghan RVM Model 761 is a Spirometer, Monitoring (With/Without Alarm), designed to measure and display respiratory parameters such as breathing frequency. It falls under the classification of a Class II medical device under FDA regulations, intended for use in clinical respiratory assessment.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K884942) with an advisory committee classification in Anesthesiology. It operates in clinical settings, including anesthesia monitoring, and adheres to FDA’s Special Controls for breathing frequency monitors. No sterility or single-use specifications are indicated in the regulatory data.

Frequently asked questions

What clinical setting is the Monaghan RVM Model 761 primarily used in, and what respiratory parameter does it measure?

The Monaghan RVM Model 761 is designed for clinical respiratory assessment, particularly in anesthesia monitoring settings. It measures and displays breathing frequency, which is critical for monitoring patients under anesthesia to ensure safe respiratory function during procedures.

Is the Monaghan RVM Model 761 intended for single-use or reusable applications, and how does this affect its maintenance?

The device is explicitly described as a reusable medical instrument, meaning it is not single-use. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed as per clinical guidelines to ensure accuracy, reliability, and infection control in repeated use.

What regulatory pathway was followed for FDA clearance of the Monaghan RVM Model 761, and what classification does it hold?

The Monaghan RVM Model 761 received FDA clearance through a Traditional 510(k) pathway with the clearance number K884942. It is classified as a Class II medical device under FDA regulations, specifically for spirometry monitoring with or without alarms, and adheres to Special Controls for breathing frequency monitors as outlined in regulation number 868.1850.

Does the Monaghan RVM Model 761 include alarm functionality, and if so, how might this benefit clinical use?

Yes, the device is designed as a Spirometer, Monitoring (With/Without Alarm), meaning it can optionally include alarm functionality to alert clinicians to abnormal breathing frequency patterns. This feature enhances patient safety by providing immediate alerts during critical monitoring scenarios, such as in anesthesia or intensive care settings.

Are there multiple models or variations of the Monaghan RVM, and if so, how are they differentiated?

The provided data lists multiple registration numbers (e.g., 3017200972, 3013557562, etc.), which may correspond to different lot numbers, serial batches, or minor variations of the Model 761 under the same core design. However, no explicit differentiation between models is described in the regulatory data—these numbers likely track inventory or compliance rather than distinct clinical specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MONAGHAN RVM, MODEL 760 AND 761 510 (k) K863612 - FDA.report, PDF K863612 - Monaghan Rvm, Model 760 and 761, K853047 FDA 510(k) - MONAGHAN RVM | Monaghan Medical Corp., MONAGHAN RVM, MODEL 760 OR MODEL 761 - Innolitics, Monaghan Rvm, Model 761 510 (k) FDA Premarket Notification K884942 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monaghan Medical Corp.

Sources (1)

  • FDA 510(k) K884942 24 fields · synced Sep 19, 2026